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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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RESPIRONICS CALIFORNIA, INC V200 VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number V200
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
The customer reported the touchscreen inoperable.No patient involvement reported.
 
Manufacturer Narrative
Date of event: (b)(6) 2018.Date of report: 31/aug/2018.Date received by manufacturer: 30/jul/2018.The touch screen control board and cables were returned for evaluation.The parts were tested and no faults could be found.The parts performed as designed.No errors were produced during approximately 4 hours of testing.Cause of the event could not be determined.
 
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Brand Name
V200 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
neisha markham
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key7541499
MDR Text Key109288215
Report Number2031642-2018-01066
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberV200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/24/2018
Initial Date FDA Received05/24/2018
Supplement Dates Manufacturer Received04/24/2018
Supplement Dates FDA Received08/31/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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